Use of Tranexamic Acid in Weight-loss surgery (Sleeve) x bleeding outcome

Use of Tranexamic Acid in Bariatric surgery (Sleeve) x bleeding outcome: a controlled study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-4w39gz

Enrollment

Unknown

Registered

2020-06-09

Start date

2018-09-12

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

Group 1 (30 patients) - Tranexamic acid. Injectable tranexamic acid (1g - EV), single dose, will be administered before the start of Sleeve bariatric surgery. Group 2 (31 patients) - Control. No proce

Drug

Procedure/surgery

E02.570.500.062

D02.241.223.268.860

Eligibility

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Age between 18 and 65 years; both genders; physical status ASA-I or II (American Society of Anesthesiologists); submitted to bariatric surgery (Sleeve); signed informed consent form.

Exclusion criteria

Exclusion criteria: History of thromboembolic disease; severe comorbidity (American Society of Anesthesiologists criteria); patients using platelet-inhibiting or anticoagulant drugs; carriers of active intravascular coagulation; acute occlusive vasculopathy; known hypersensitivity to the components of the tranexamic acid formula.

Design outcomes

Primary

Measure	Time frame
Expected outcome 1: Reduction of intraoperative bleeding with the use of tranexamic acid, in comparison with the control group. Evaluated by data collection related to intraoperative bleeding (Blood volume in the suction pump and estimated volume by weight of gases), in addition, evaluation by hematological data (complete blood count, coagulogram and fibrinogen) at the time of induction of anesthesia and 24 hours after the operation.;Outcome 1: Bleeding volume was greater in the control group than in the tranexamic acid group (p = 0.013). There was no difference regarding the weight of the gauze and the number of interventions to control bleeding (sutures and clips). In the variables evaluated in the postoperative period, it can be seen that patients in the tranexamic acid group had a higher hemoglobin value (p = 0.023), hematocrit (p = 0.000), greater prothrombin activity (AP) (p = 0.004) and lower value of INR (p = 0.013) than the control group. The staple line oversewing group also had a higher hematocrit value (p = 0.000) and AP (p = 0.004) than the control group.	—

Measure

Time frame

Expected outcome 1: Reduction of intraoperative bleeding with the use of tranexamic acid, in comparison with the control group. Evaluated by data collection related to intraoperative bleeding (Blood volume in the suction pump and estimated volume by weight of gases), in addition, evaluation by hematological data (complete blood count, coagulogram and fibrinogen) at the time of induction of anesthesia and 24 hours after the operation.;Outcome 1: Bleeding volume was greater in the control group than in the tranexamic acid group (p = 0.013). There was no difference regarding the weight of the gauze and the number of interventions to control bleeding (sutures and clips). In the variables evaluated in the postoperative period, it can be seen that patients in the tranexamic acid group had a higher hemoglobin value (p = 0.023), hematocrit (p = 0.000), greater prothrombin activity (AP) (p = 0.004) and lower value of INR (p = 0.013) than the control group. The staple line oversewing group also had a higher hematocrit value (p = 0.000) and AP (p = 0.004) than the control group.

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Secondary

Measure	Time frame
Expected outcome 2: A reduction in the length of hospital stay is expected for groups with the receipt of intervention, either by receiving tranexamic acid, or by receiving the stapling line oversewing. The length of hospital stay will be recorded by the number of days, and the discharge will follow the ERABS (Enhanced Recovery After Bariatric Surgery) criteria, and being classified as: early discharge equal to 6 pm on the 1st postoperative day, normal discharge equal to 8 h on the 2nd postoperative day and late discharge equal, or greater than 48 h after the end of surgery.;Outcome 2: Four patients in the control group had to remain hospitalized for 3 days. Thus, the length of stay was longer in the control group (median 2; 2-3) than in the tranexamic acid (median 2; 2-2) and oversewing(median 2; 2-2) groups (p = 0.019).;Expected outcome 3: No negative interference from the use of tranexamic acid in thromboembolic events, compared to the control group or the oversewing group. All patients will be followed for at least 6 months after surgery for thromboembolic events.;Outcome 3: No patient in the study had thrombotic complications related to the use of tranexamic acid.;Expected outcome 4: Reduction in surgical and anesthesia time for patients who received tranexamic acid, compared to the control group or the oversewing group. The surgical and anesthesia time will be measured in hours and recorded in the patient's electronic medical record.;Outcome 4: There was no statistically significant difference in surgical time or anesthesia time between groups.;Expected outcome 5: Reduction in the number of postoperative complications and the need to re-approach patients, for bleeding control, through the use of oversewing techniques or the use of tranexamic acid. Patients will be followed up and all complications will be recorded in their electronic medical records, including, in the case of surgical overhang.;Outcome found 5: In the control group, one patient had a large hem	—

Measure

Time frame

Expected outcome 2: A reduction in the length of hospital stay is expected for groups with the receipt of intervention, either by receiving tranexamic acid, or by receiving the stapling line oversewing. The length of hospital stay will be recorded by the number of days, and the discharge will follow the ERABS (Enhanced Recovery After Bariatric Surgery) criteria, and being classified as: early discharge equal to 6 pm on the 1st postoperative day, normal discharge equal to 8 h on the 2nd postoperative day and late discharge equal, or greater than 48 h after the end of surgery.;Outcome 2: Four patients in the control group had to remain hospitalized for 3 days. Thus, the length of stay was longer in the control group (median 2; 2-3) than in the tranexamic acid (median 2; 2-2) and oversewing(median 2; 2-2) groups (p = 0.019).;Expected outcome 3: No negative interference from the use of tranexamic acid in thromboembolic events, compared to the control group or the oversewing group. All patients will be followed for at least 6 months after surgery for thromboembolic events.;Outcome 3: No patient in the study had thrombotic complications related to the use of tranexamic acid.;Expected outcome 4: Reduction in surgical and anesthesia time for patients who received tranexamic acid, compared to the control group or the oversewing group. The surgical and anesthesia time will be measured in hours and recorded in the patient's electronic medical record.;Outcome 4: There was no statistically significant difference in surgical time or anesthesia time between groups.;Expected outcome 5: Reduction in the number of postoperative complications and the need to re-approach patients, for bleeding control, through the use of oversewing techniques or the use of tranexamic acid. Patients will be followed up and all complications will be recorded in their electronic medical records, including, in the case of surgical overhang.;Outcome found 5: In the control group, one patient had a large hem

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Countries

Brazil

Contacts

Public ContactCiro;Plinio Fé;Leal

HOSPITAL SÃO DOMINGOS;HOSPITAL SÃO DOMINGOS

cirosousademouraf@gmail.com;pliniocunhaleal@hotmail.com98988207845;098988522021

Outcome results

None listed

Source: REBEC (via WHO ICTRP)